Manufacturing Associate II
$61,500–$76,900 year
On-siteMorrisville, North Carolina, United States
Job Summary
Participate in process validation activities for the new multi-product manufacturing facility and produce regenerative medicines while observing critical processing steps. Create, redline, and review process Standard Operating Procedures (SOPs), execute real-time batch record reviews, and monitor alarms to ensure production accuracy. Perform inventory control, cycle counts, and resolve discrepancies regarding product accountability. Collaborate with stakeholders to address production issues and assist in closing deviations. Maintain compliance with OSHA and regulatory safety procedures, actively participate in waste walkthroughs, and contribute to 5S, kaizen, and lean initiatives.
Required Qualifications
- 2+ years of experience in a cGMP manufacturing environment
- degree in science or a technical related discipline
- minimum of 3+ years of cGMP manufacturing experience
- high school diploma
- Prior experience supporting new facility start-up and validation
- Experience in aseptic operations
- Must be able to work in a controlled or clean room environment requiring special gowning including a face mask
- Background in cell/tissue culture, BSCs, isolators, aseptic gowning and qualification, and ISO 7/8 cleanroom operations
- Experience with batch record execution, including good documentation practices
- Must be able to work in a controlled or clean room environment requiring special gowning including a face mask
- Ability to sit, stand, walk regularly, and occasionally lift 20-25 pounds
- Must be able to travel domestically and internationally as needed
- Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test
- Excellent written and oral communication skills
- Requires ability to use a personal computer for extended periods of time
- Must be able to exercise appropriate judgment as necessary
- Requires a high level of initiative and independence
Desired Qualifications
- Prior experience supporting new facility start-up and validation preferred
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